Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil

• Status: Completed
• Trial end date: 2017-10-10
• Target enrollment: 0
• Participant gender: Male

Summary

A randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil administered in healthy male volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuyu Pharma, Inc.
• Treatments: Dutasteride; Tadalafil

Criteria

Inclusion Criteria:

• Age 19 to 45 years

• BMI score 19 kg/m2 to 28 kg/m2

• SBP < 140 mmHg and ≤ 90 mmHg or DBP < 90 mmHg and ≥ 50 mmHg

• Eligible according to the laboratory results of hematology, blood chemistry and urinalysis

• Voluntarily signed the informed consent form

Exclusion Criteria:

• Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months

• History of hypersensitivity

• history of Cardiovascular disease

• History of degenerative Retina disease

• Lactose intolerance

• Medical history of vision loss

• Clinically significant disorders of allergy, drug hypersensitivity reaction, hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system

• Donated whole blood (transfusion, apheresis etc..) within 60 days

• Participated and administered the investigational products in other clinical trial within 90 days

• Taking drugs which may affect Clinical trial within 30 days

• Smoked more than 10 cigarettes a day for past 30 days

• Excessive alcohol consumption (> 3 units/week, 1 unit)

• Taking food which may affect Clinical trial within 7 days

• Positive result from Urinary test

• Positive result from Serum test

• Clinically significant disorders result from Electrocardiography test

• Not eligible due to investigator's judgments